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510(k) K030768

CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL by Cliniqa Corporation — Product Code JJT

K030768 is an FDA 510(k) premarket notification submitted by Cliniqa Corporation for the device "CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL". The FDA issued a decision of Substantially Equivalent on March 21, 2003. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Cliniqa Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2003
Date Received
March 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Cliniqa Corporation

  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)
  • K121237 — BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA (May 18, 2012)
  • K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 (April 21, 2009)
  • K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (January 16, 2009)
  • K082107 — CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 (September 17, 2008)
  • K080973 — CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC M (June 2, 2008)
  • K070741 — CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & (May 4, 2007)
  • K062916 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 (October 23, 2006)
  • K061182 — CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS (May 25, 2006)
  • K060322 — CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMIS (March 21, 2006)

Other clearances for product code JJT

  • K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (December 14, 2009)
  • K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (October 3, 2006)
  • K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (January 24, 2003)
  • K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (May 24, 2002)
  • K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (September 6, 2001)
  • K993723 — CARDIASURE CARDIAC MARKERS CONTROL (November 23, 1999)
  • K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (November 16, 1999)
  • K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (August 30, 1999)
  • K984437 — QUANTEX ASO-CRP-RP CONTROL II (February 2, 1999)
  • K984277 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (December 9, 1998)

FDA data resources